Home FDA labels 40eb0186-e55e-4f93-9233-996297910dbd FDA label 40eb0186-e55e-4f93-9233-996297910dbd openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 40eb0186-e55e-4f93-9233-996297910dbd
SPL ID 40eb0186-e55e-4f93-9233-996297910dbd
Version 1
Effective date 2012-03-16
Source export date 2026-09-28
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:31:43 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings WARNING Furosemide USP is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient’s needs (see DOSAGE AND ADMINISTRATION).
warnings WARNINGS In patients with hepatic cirrhosis and ascites, furosemide therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) (see PRECAUTIONS, Drug Interactions ).
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions ADVERSE REACTIONS Adverse reactions are categorized below by organ system and listed by decreasing severity. Gastrointestinal System Reactions 1. hepatic encephalopathy in patients with hepatocellular insufficiency 6. oral and gastric irritation 2. pancreatitis 7. cramping 3. jaundice (intrahepatic cholestatic jaundice) 8. diarrhea 4. increased liver enzymes 9. constipation 5. anorexia 10. nausea 11. vomiting Systemic Hypersensitivity Reactions 1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock) 3. interstitial nephritis 2. systemic vasculitis 4. necrotizing angiitis Central Nervous System Reactions 1. tinnitus and hearing loss 4. dizziness 2. paresthesias 5. headache 3. vertigo 6. blurred vision 7. xanthopsia Hematologic Reactions 1. aplastic anemia 2. thrombocytopenia 5. leukopenia 3. agranulocytosis 6. anemia 4. hemolytic anemia 7. eosinophilia Dermatologic - Hypersensitivity Reactions 1. exfoliative dermatitis 6. urticaria 2. bullous pemphigoid 7. rash 3. erythema multiforme 8. pruritus 4. purpura 9. Stevens-Johnson Syndrome 5. photosensitivity 10. toxic epidermal necrolysis Cardiovascular Reaction 1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics. 2. Increase in cholesterol and triglyceride serum levels. Other Reactions 1. hyperglycemia 6. restlessness 2. glycosuria 7. urinary bladder spasm 3. hyperuricemia 8. thrombophlebitis 4. muscle spasm 9. fever 5. weakness Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.
adverse reactions table <table border="single" width="468.000" ID="id_6802c74a-f0e5-4745-ab6a-176e62b82d15"> <col width="53.2%"/> <col width="46.8%"/> <tbody> <tr ID="id_b15c7461-983c-4385-a8fb-7cf6ca420413"> <td align="left" valign="top" colspan="2" styleCode="Botrule"> <content styleCode="bold">Gastrointestinal System Reactions </content> </td> </tr> <tr ID="id_83d0b5e5-9a76-4ec2-ac38-7a6518c174b3"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> 1. hepatic encephalopathy in patients with</paragraph> hepatocellular insufficiency </td> <td align="left" valign="top" styleCode="Botrule"> 6. oral and gastric irritation</td> </tr> <tr ID="id_c61e0d08-d2ab-40e8-a744-843254f32a2b"> <td align="left" valign="top" styleCode="Botrule Rrule"> 2. pancreatitis </td> <td align="left" valign="top" styleCode="Botrule"> 7. cramping</td> </tr> <tr ID="id_ed0966e0-7d69-4310-a4ff-3d60a5282db7"> <td align="left" valign="top" styleCode="Botrule Rrule"> 3. jaundice (intrahepatic cholestatic jaundice) </td> <td align="left" valign="top" styleCode="Botrule"> 8. diarrhea</td> </tr> <tr ID="id_a72b7a06-0d45-4ecc-8f60-12fe4c0f0d10"> <td align="left" valign="top" styleCode="Botrule Rrule"> 4. increased liver enzymes</td> <td align="left" valign="top" styleCode="Botrule"> 9. constipation</td> </tr> <tr ID="id_11f16571-6021-48a6-bab7-0f56741d3458"> <td align="left" valign="top" styleCode="Botrule Rrule"> 5. anorexia </td> <td align="left" valign="top" styleCode="Botrule">10. nausea</td> </tr> <tr ID="id_fc368571-7f80-4c4f-b79b-61b22dbb53f7"> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule">11. vomiting</td> </tr> <tr ID="id_d5c1fe34-bcd4-4fe4-8635-814e97ab6b76"> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> <td align="left" valign="top" styleCode="Botrule"> </td> </tr> <tr ID="id_ae218627-5ec7-41e6-b727-99882399a805"> <td align="left" valign="top" colspan="2" styleCode="Botrule"> <content styleCode="bold">Systemic Hypersensitivity Reactions</content> </td> </tr> <tr ID="id_6f5124c8-6323-4217-b870-5886833a5b13"> <td align="left" valign="top" styleCode="Botrule Rrule"> 1. Severe anaphylactic or anaphylactoid reactions (e.g., with shock)</td> <td align="left" valign="top" styleCode="Botrule"> 3. interstitial nephritis </td> </tr> <tr ID="id_362c952c-3587-4433-8138-48996510c9fe"> <td align="left" valign="top" styleCode="Botrule Rrule"> 2. systemic vasculitis </td> <td align="left" valign="top" styleCode="Botrule"> 4. necrotizing angiitis</td> </tr> <tr ID="id_1e3c26ae-4b7f-406a-b0cb-fe4b67ea8b10"> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> <td align="left" valign="top" styleCode="Botrule"> </td> </tr> <tr ID="id_5032ff6a-0cf2-4f94-8878-682fc6bbf4e5"> <td align="left" valign="top" colspan="2" styleCode="Botrule"> <content styleCode="bold">Central Nervous System Reactions</content> </td> </tr> <tr ID="id_a5b24cdf-1313-4f1b-9350-f092eb128f74"> <td align="left" valign="top" styleCode="Botrule Rrule"> 1. tinnitus and hearing loss </td> <td align="left" valign="top" styleCode="Botrule"> 4. dizziness </td> </tr> <tr ID="id_8be7deb4-55e7-44af-b77a-09182a5336f5"> <td align="left" valign="top" styleCode="Botrule Rrule"> 2. paresthesias </td> <td align="left" valign="top" styleCode="Botrule"> 5. headache </td> </tr> <tr ID="id_a80d7bd8-4960-4f10-b36e-89c9a372420d"> <td align="left" valign="top" styleCode="Botrule Rrule"> 3. vertigo </td> <td align="left" valign="top" styleCode="Botrule"> 6. blurred vision </td> </tr> <tr ID="id_c03af928-9237-4f42-8ea9-46122b99a47e"> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> <td align="left" valign="top" styleCode="Botrule"> 7. xanthopsia </td> </tr> <tr ID="id_66175d3a-c82f-4b9b-aa34-1ad59a7e93a7"> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> <td align="left" valign="top" styleCode="Botrule"> </td> </tr> <tr ID="id_031fa100-a724-4dac-8ff3-22390289ae29"> <td align="left" valign="top" colspan="2" styleCode="Botrule"> <content styleCode="bold">Hematologic Reactions</content> </td> </tr> <tr ID="id_179c3278-88eb-49d2-bc26-79eb13c93a90"> <td align="left" valign="top" styleCode="Botrule Rrule"> 1. aplastic anemia </td> <td align="left" valign="top" styleCode="Botrule"/> </tr> <tr ID="id_d0b94163-e1a8-44d6-a3de-04bbfda764fc"> <td align="left" valign="top" styleCode="Botrule Rrule"> 2. thrombocytopenia </td> <td align="left" valign="top" styleCode="Botrule"> 5. leukopenia </td> </tr> <tr ID="id_47249fd1-d3b1-4cbd-bdd0-0a862fb3f6d8"> <td align="left" valign="top" styleCode="Botrule Rrule"> 3. agranulocytosis</td> <td align="left" valign="top" styleCode="Botrule"> 6. anemia </td> </tr> <tr ID="id_3b7dd622-32a2-46f2-9475-2f64c34d1c4b"> <td align="left" valign="top" styleCode="Botrule Rrule"> 4. hemolytic anemia</td> <td align="left" valign="top" styleCode="Botrule"> 7. eosinophilia </td> </tr> <tr ID="id_1347e2d6-ef98-4b07-941d-25a19c953abd"> <td align="left" valign="top" styleCode="Botrule Rrule"/> <td align="left" valign="top" styleCode="Botrule"/> </tr> <tr ID="id_8127673b-bcc2-4bca-b317-54d38ae2da84"> <td align="left" valign="top" styleCode="Botrule Rrule"> <content styleCode="bold">Dermatologic - Hypersensitivity Reactions</content> </td> <td align="left" valign="top" styleCode="Botrule"> </td> </tr> <tr ID="id_d8706c64-fdb4-4e5d-9900-d021f1655bfd"> <td align="left" valign="top" styleCode="Botrule Rrule"> 1. exfoliative dermatitis </td> <td align="left" valign="top" styleCode="Botrule"> 6. urticaria </td> </tr> <tr ID="id_5e737d52-1180-4ee9-94fa-f3fcb19ac110"> <td align="left" valign="top" styleCode="Botrule Rrule"> 2. bullous pemphigoid </td> <td align="left" valign="top" styleCode="Botrule"> 7. rash </td> </tr> <tr ID="id_f063b5f6-8c8f-4069-b34b-0f17d74faa20"> <td align="left" valign="top" styleCode="Botrule Rrule"> 3. erythema multiforme </td> <td align="left" valign="top" styleCode="Botrule"> 8. pruritus </td> </tr> <tr ID="id_e1f8837c-9041-47ee-83ea-ee61687e151f"> <td align="left" valign="top" styleCode="Botrule Rrule"> 4. purpura </td> <td align="left" valign="top" styleCode="Botrule"> 9. Stevens-Johnson Syndrome </td> </tr> <tr ID="id_6498bf2b-7e8e-4bb6-8188-d8dbf7fcd20c"> <td align="left" valign="top" styleCode="Botrule Rrule"> 5. photosensitivity </td> <td align="left" valign="top" styleCode="Botrule">10. toxic epidermal necrolysis</td> </tr> <tr ID="id_71adf05e-2e20-42cc-af91-d1ad8b6b1ca6"> <td align="left" valign="top" styleCode="Botrule Rrule"> </td> <td align="left" valign="top" styleCode="Botrule"> </td> </tr> <tr ID="id_25365546-e3f0-4eac-af3f-39e58a3cec21"> <td align="left" valign="top" colspan="2" styleCode="Botrule"> <content styleCode="bold">Cardiovascular Reaction</content> </td> </tr> <tr ID="id_2e8fb6d1-84f7-4b94-869c-e03b78304720"> <td align="left" valign="top" colspan="2" styleCode="Botrule"> <paragraph>1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.</paragraph>2. Increase in cholesterol and triglyceride serum levels.</td> </tr> <tr ID="id_bc550f2b-e6fb-4a80-a3ae-3957c34f978f"> <td align="left" valign="top" colspan="2" styleCode="Botrule"/> </tr> <tr ID="id_7267bc00-8793-4fa5-b976-883d14764f57"> <td align="left" valign="top" colspan="2" styleCode="Botrule"> <content styleCode="bold">Other Reactions</content> </td> </tr> <tr ID="id_46ea58c3-d2e9-4563-b531-d04557ec58e3"> <td align="left" valign="top" styleCode="Botrule Rrule"> 1. hyperglycemia </td> <td align="left" valign="top" styleCode="Botrule"> 6. restlessness </td> </tr> <tr ID="id_ac4c4a91-692a-48e2-b123-b81fe5110d39"> <td align="left" valign="top" styleCode="Botrule Rrule"> 2. glycosuria </td> <td align="left" valign="top" styleCode="Botrule"> 7. urinary bladder spasm </td> </tr> <tr ID="id_d9269942-49eb-4239-811e-872fa72ad6a1"> <td align="left" valign="top" styleCode="Botrule Rrule"> 3. hyperuricemia </td> <td align="left" valign="top" styleCode="Botrule"> 8. thrombophlebitis </td> </tr> <tr ID="id_5358e44d-7e71-46e7-b93e-5b79ed4998e7"> <td align="left" valign="top" styleCode="Botrule Rrule"> 4. muscle spasm </td> <td align="left" valign="top" styleCode="Botrule"> 9. fever </td> </tr> <tr ID="id_50340344-7a84-4b4d-be46-e02c5dc56b8c"> <td align="left" valign="top" styleCode="Botrule Rrule"> 5. weakness </td> <td align="left" valign="top" styleCode="Botrule"> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.